A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
Overview[ - collapse ][ - ]
Purpose | Examine the safety and efficacy of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures |
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Condition | Epilepsies, Partial |
Intervention | Drug: gabapentin |
Phase | Phase 3 |
Sponsor | Pfizer |
Responsible Party | Pfizer |
ClinicalTrials.gov Identifier | NCT00620555 |
First Received | February 11, 2008 |
Last Updated | January 24, 2012 |
Last verified | November 2011 |
Tracking Information[ + expand ][ + ]
First Received Date | February 11, 2008 |
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Last Updated Date | January 24, 2012 |
Start Date | May 2008 |
Estimated Primary Completion Date | December 2010 |
Current Primary Outcome Measures | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related) [Time Frame: up to 53 weeks] [Designated as safety issue: Yes]Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. Severe AEs: those which interferes significantly with participant's usual function. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures |
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Official Title | A 52 Weeks, Open-Label, Multicenter Study Evaluating The Efficacy And Safety Of Gabapentin As Adjunctive Therapy In Pediatric Patients Who Have Completed The 12 Weeks Treatment In Study A9451162 (NCT00603473) |
Brief Summary | Examine the safety and efficacy of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Epilepsies, Partial |
Intervention | Drug: gabapentin Orally administered gabapentin |
Study Arm (s) | Experimental: gabapentin |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 65 |
Estimated Completion Date | December 2010 |
Estimated Primary Completion Date | December 2010 |
Eligibility Criteria | Inclusion Criteria: - Completion of study A9451162 (NCT00603473) Exclusion Criteria: - Seizures related to drugs or acute medical illness - History of any serious medical or psychiatric disorder |
Gender | Both |
Ages | 3 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Japan |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00620555 |
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Other Study ID Numbers | A9451165 |
Has Data Monitoring Committee | No |
Information Provided By | Pfizer |
Study Sponsor | Pfizer |
Collaborators | Not Provided |
Investigators | Study Director: Pfizer CT.gov Call Center Pfizer |
Verification Date | November 2011 |
Locations[ + expand ][ + ]
Pfizer Investigational Site | Obu-shi,Morioka-machi, Aichi, Japan |
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Pfizer Investigational Site | Jonan-ku, Fukuoka, Japan |
Pfizer Investigational Site | Kobe, Hyogo, Japan |
Pfizer Investigational Site | Suma-Ku,Kobe, Hyogo, Japan |
Pfizer Investigational Site | Kanazawa, Ishikawa, Japan |
Pfizer Investigational Site | Zentsuuji, Kagawa, Japan |
Pfizer Investigational Site | Yokohama, Kanagawa Pref., Japan |
Pfizer Investigational Site | Sendai-shi, Miyagi-ken, Japan |
Pfizer Investigational Site | Showa-Ku, Nagoya, Japan |
Pfizer Investigational Site | Niigata-shi, Niigata, Japan |
Pfizer Investigational Site | Kurashiki-City, Okayama Pref., Japan |
Pfizer Investigational Site | Okayama-shi, Okayama, Japan |
Pfizer Investigational Site | Izumi-shi, Osaka, Japan |
Pfizer Investigational Site | Miyakojima-ku, Osaka, Japan |
Pfizer Investigational Site | Suita, Osaka, Japan |
Pfizer Investigational Site | Shizuoka-shi, Shizuoka, Japan |
Pfizer Investigational Site | Kodaira, Tokyo, Japan |
Pfizer Investigational Site | Setagaya-ku, Tokyo, Japan |
Pfizer Investigational Site | Shinjuku-ku, Tokyo, Japan |
Pfizer Investigational Site | Hiroshima, Japan |
Pfizer Investigational Site | Saitama, Japan |
Pfizer Investigational Site | Yamagata, Japan |